Mycoket^® (Ointment) Instructions for Use

Marketing Authorization Holder

Sintez PJSC (Russia)

ATC Code

D01AC08 (Ketoconazole)

Active Substance

Ketoconazole (Rec.INN registered by WHO)

Dosage Form

Mycoket®

Ointment for external use 2%: tubes 15 g

Dosage Form, Packaging, and Composition

Ointment for external use 2% white or white with a creamy or pinkish tint.

Excipients: methylparahydroxybenzoate (methylparaben or nipagin) – 200 mg, propylene glycol – 10 g, glycerol (distilled glycerin) – 10 g, petrolatum (medical petrolatum) – 15 g, emulsifier No. 1 – 8 g, water (purified water) – up to 100 g.

15 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Ketoconazole is a broad-spectrum antifungal agent, a synthetic derivative of imidazole (imidazoledioxolane). It has a fungicidal or fungistatic effect.

The drug is active against dermatophytes Trichophyton spp. (including Trichophyton rubrum, Trichophyton mentagrophytes), Microsporum spp. (including Microsporum canis), Epidermophyton floccosum, yeast-like fungi of the genus Candida spp. (including Candida albicans), Pityrosporum spp. (including Pityrosporum ovale, Pityrosporum orbiculare, Malassezia furfur).

Ketoconazole is also active against Staphylococcus spp. and Streptococcus spp.

The mechanism of action of ketoconazole consists in inhibiting the biosynthesis of ergosterol, triglycerides, and phospholipids necessary for the synthesis of the fungal cell wall, which leads to a violation of the permeability of the fungal cell wall and to the loss of the ability of fungi to form filaments and colonies.

Mycoket^® ointment acts very quickly on itching in dermatophytic and yeast infections, including skin lesions caused by Pityrosporum spp. At the same time, symptomatic improvement is observed even before the first signs of recovery appear.

Pharmacokinetics

When applied externally, Ketoconazole is not absorbed into the systemic circulation; with prolonged use of the ointment, the concentration of ketoconazole in the blood is not determined.

Indications

Treatment of skin mycoses caused by fungi sensitive to the drug

• Dermatomycosis of smooth skin;
• Tinea cruris;
• Tinea of the hands and feet;
• Skin candidiasis;
• Pityriasis (tinea) versicolor;
• Seborrheic dermatitis caused by Pityrosporum ovale.

ICD codes

Dosage Regimen

Dermatomycosis of smooth skin, tinea cruris, tinea of the hands and feet, skin candidiasis, pityriasis (tinea) versicolor apply the ointment 1 time/day to the affected skin and the area directly adjacent to it.

Seborrheic dermatitis the ointment is applied to the affected area 1-2 times/day depending on the severity of the lesion.

Treatment should be continued for a sufficient period of time, at least for several days after the disappearance of all symptoms of the disease. The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks of treatment.

The usual duration of treatment is as follows: dermatomycosis of smooth skin – 3-4 weeks, tinea pedis – 4-6 weeks, tinea cruris – 2-4 weeks, skin candidiasis – 2-3 weeks, pityriasis versicolor – 2-3 weeks. The total duration of treatment for seborrheic dermatitis is 2-4 weeks. For maintenance therapy for seborrheic dermatitis, the ointment is applied 1 or 2 times a week.

Adverse Reactions

Rare – 1/10,000 prescriptions (> 0.01% and < 0.1%).

From the skin: rarely – irritation and burning sensation; local skin manifestations of an allergic nature (such as contact dermatitis) caused by the active component of the ointment – ketoconazole or one of the excipients – propylene glycol.

Contraindications

• Hypersensitivity to ketoconazole or any of the excipients of the drug.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is not contraindicated, because when applied externally, Ketoconazole is not absorbed into the systemic circulation.

Special Precautions

For external use only.

The ointment should not be used in ophthalmic practice. Avoid contact with eyes.

General hygiene measures should be observed to control sources of infection and reinfection.

Effect on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles, mechanisms, and engage in other hazardous activities that require special attention and quick reactions.

Overdose

Using the ointment in excessive amounts may lead to erythema, swelling, and a burning sensation, which usually disappear after discontinuation of therapy.

In case of accidental ingestion of the ointment, gastric lavage should be performed. Symptomatic therapy is carried out.

Drug Interactions

Drug interactions of ketoconazole have not been described.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature from 15°C (59°F) to 20°C (68°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.